Vascular wound closing apparatus and method

ABSTRACT

Wound closure apparatus is provided including a body having an elongated, lowermost force-transmitting surface operable to be placed in a proximal, external, wound-closing position on a patient, together with a force-exerting assembly coupled with the body and operable to exert a downwardly directed force serving to generate wound-closing pressure against the patient&#39;s tissue. The force-transmitting surface is preferably three-dimensionally asymmetric so that forces of different magnitude are exerted at different locations along the length of the surface. The apparatus is especially designed for the closure of wounds attendant to endovascular interventions, e.g., a femoral artery puncture wound incident to percutaneous cardiac intervention (PCI), and is capable of quickly effecting wound closure with a time-to-ambulation (TTA) of approximately 60 minutes, and with a very low complication rate.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a division of identically-titled application Ser.No. 13/421,253 filed Mar. 15, 2012, which is a continuation ofidentically-titled application Ser. No. 13/105,255 filed May 11, 2011,and also claims the benefit of Provisional Application Ser. No.61/461,923, filed Jan. 25, 2011, and Provisional Application S/N61,463,373, filed Feb. 16, 2011, all of which are incorporated byreference herein in their entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention is broadly concerned with improved apparatus andmethods for closure of wounds in the tissue of patients, and especiallywounds attendant to endovascular interventions, such as percutaneouscardiac intervention (PCI,) wherein closure is defined as the time fromremoval of the catheter to ambulating the patient. More particularly,the invention is concerned with such apparatus and methods which employsa rigid wound-closing body adapted to be placed adjacent and along thelength of the wound, together with a force-exerting assembly operable tocreate forces which generate relatively high pressures on the patient'sskin and tissue adjacent the wound. In preferred forms, the rigid bodyhas a three-dimensionally asymmetric lower force-transmitting surface soas to exert forces of different magnitudes at different locations alongthe force-transmitting surface. Also, the force-transmitting surface ispreferably exerted substantially constantly and in a substantiallytime-invariant manner.

2. Description of the Prior Art

Endovascular interventions such as PCI are widely accepted as apractical treatment option for coronary artery disease. For example,femoral artery puncture is commonly used in endovascular diagnostic andinterventional procedures. Alternately, access may be made via the rightradial or brachial artery. Such procedures are now commonly performed onan out-patient basis. In the case of a femoral arterial intervention, apuncture wound is made with a cannula to create an oblique subcutaneoustract and a terminal arteriotomy, followed by placement of a sheathwithin the tract. A catheter is then threaded through the sheath andinto the adjacent artery, so that access can be had to the coronaryarteries. After the diagnosis or intervention is completed, the catheteris withdrawn, the sheath is removed, and steps must be taken to closethe wound. Wound closure typically involves compression to controlbleeding until hemostasis occurs. Ideally, wound closure serves tominimize blood loss, effect hemostasis, and render the patientambulatory in a relatively short period of time.

Poorly executed wound closures may give rise to complications which arecostly, increase hospital stays and affect morbidity. For example,inadequate hemostasis can lead to significant blood loss, patientdiscomfort, vessel occlusion, thrombosis, formation of arteriovenousfistula, and pseudoaneurysm requiring surgical intervention and/or stepsto avoid infections. Complications at the access site due to arterialcannulation occur in 1%-5% of cases, but may be as high as 14% with someinterventional procedures.

Traditionally, wound closure has been a manual operation where aphysician or nurse used manual hand pressure, using either one or twohands. One-handed manual pressure is usually carried out over a periodof 30 minutes with a time to ambulation (TTA) of 4-6 hours. Two-handedmanual pressure (often referred to as the “gold standard” of woundclosure) ideally achieves optimal wound closure. In this technique, thehealthcare professional's left hand exerts a semi-occlusive pressureupstream (closer to the heart) of the arteriotomy to moderate bloodpressure fluctuations and to reduce the mean blood pressure from theheart without denying blood flow downstream. The professional's righthand holds an occlusive pressure over the arteriotomy, tract, andinsertion site. This is continued for a period of approximately 30minutes. However, in actual practice, there are a number of significantproblems. For example, manual pressure that is too firm does not allowsufficient clotting factors to accumulate at the arteriotomy. Moreover,manual pressure along the tract varies because the tips of the fourfingers of the right hand are not flat. Even more important, the personexerting manual pressure can tire during the 30-minute holding time, orthe fingers may move or may not be placed properly. The person may alsotemporarily stop the application of pressure to examine the wound,causing a disruption of the maturing clot. Finally, different body typespresent different manual pressure issues, e.g., if the panniculusintrudes on the person's left hand, pressure variations may be inducedas the patient breathes and the panniculus moves. TTA for thistwo-handed procedure is again normally 4-6 hours.

Manual techniques can be supplemented with use of applied hemostasisadjuncts, which reduce the time to hemostasis (TTH) to 5-6 minutes, butdo not lower TTA because there is no force on the arteriotomy afterhemostasis is achieved. Manual pressure may also be supplemented withexternal devices, such as C-clamps or sand bags. These combinedtechniques have many of the same problems as straightforward manualpressure closures, and the external devices may be difficult to deployon obese patients. Thus, while manual procedures are of long standing,they are deficient in that they can be tiring, require careful training,and represent inefficient use of the time of valuable medical personnel.

Other closure techniques involve use of an intra-arterial anchor givinga TTH of about five minutes and a TTA of about 2-3 hours. Drawbacks ofthese procedures include a maximum French size of 8 Fr and the fact thatthe anchor and collagen plug must be left in the body for up to 90 days.Suture-mediated intra-arterial anchor techniques have also been used,but these are deficient in that the sutures remain in the body untilabsorbed, and nonetheless require that the anchor and plug be left inthe body for an extended period. Finally, intra-tract closure has beenused where the arteriotomy is mechanically stretched and then“boomerangs” back to an 18-gauge needle diameter. In these procedures, aheparin-neutralizing drug is deployed within the wound tract, and manualpressure is still required to close the 18-gauge needle hole.

In recent years, new, larger interventional devices of up to 20 Fr arebeing used to perform tasks like operations within the heart itself. Noexisting closure device is indicated for these large interventions, andresort must be had to manual pressure or surgical techniques to closethe large wounds.

In response to these problems, various specialized vascular closuredevices (VCDs) have been proposed, such as the device disclosed in U.S.Pat. No. 5,307,811 and commercialized under the designation “FemoStop.”While these and other VCDs have achieved widespread use, no prior VCDhas fully solved the problems inherent in wound closures. Dauerman etal. (J AM COLL CARDIOLL. 2007; 50 (17) Elsevier Science)—“VascularClosure Devices: The Second Decade” described an ideal VCD:

-   -   The patient factors influencing closure success notwithstanding        the “ideal” closure device remains to be developed. What would        this device look like? 1) A single device capable of providing        successful closure for all patient and success site anatomical        variations; 2) an atraumatic device without a foreign body or        vascular alteration of the femoral artery; and 3) a        simple-to-use device with >95% procedural success and low cost.

The prior art uses the terms “pressure” and “force” loosely. A personexerting force through small fingers would apply more pressure than aperson exerting the same force with larger fingers. A furthercomplication is that the heart is beating, making the pressure (sum ofinternal and external pressure) variable. What is critical iscontrolling blood flow. If there were no flow restriction, thearteriotomy would leak, resulting in a hematoma. If there were completeflow restriction, then the downstream extremities would be starved ofoxygen and the arteriotomy would be starved of necessary clottingfactors. Hence, the ideal VCD is one in which flow is restricted, butnot excessively.

Accordingly, there is an unfulfilled need in the art for a simple-to-useVCD which closely mimics “gold standard” manual wound closure, has acomplication rate of <1%, can be used on all types of patients, givesvery low TTH and TTA values, and does not involve residual drugs,sutures, or anchoring devices.

SUMMARY OF THE INVENTION

The present invention overcomes the problems outlined above and providesVCDs and corresponding methods which have many outstanding features. Forexample, preferred embodiments of the invention used in the context ofarterial PCI procedures are characterized by:

-   -   a TTA on the order of 60 minutes for diagnostic PCI procedures;    -   a complication rate of <1%;    -   atraumatic, essentially painless wound closure with no residual        foreign materials in the wound or vascular alterations;    -   targeted asymmetric tissue pressures, with a larger        non-occlusive pressure applied upstream of the arteriotomy to        lower the patient's blood flow, with decreasing pressures        downstream of the arteriotomy;    -   substantially time-invariant wound closure pressures on the        tissue;    -   skin inversion adjacent the wound by means of a Z-stitch suture        together with a rigid, force-transmitting surface including a        transverse section positioned above the arteriotomy and        generating force of greater than about 20 lbs., but not greater        than the suture-rupturing force, and an obliquely oriented,        axially extending section, which generates decreasing pressures        downstream of the arteriotomy;    -   secondary wound closure force through use of an adhesive sheet        stretched over the device and adhered to the patient's skin on        either side of the site;    -   virtually no blood loss during wound closure;    -   different sheath sizes, blood chemistries (e.g., INR>1.5, or the        presence of blood thinners), and degrees of intervention can be        accommodated by increasing the closure time;    -   a device cost on the order of $100;    -   wound closure procedure is typically learned with less than ten        diagnostic procedures.

In the ensuing description, the methods and apparatus of the inventionare described with particular reference to wounds incident to anarterial intervention procedure. However, it should be understood thatthe invention is equally applicable to other types of vascular vesselprocedures where a wound includes an opening in a non-arterial vascularvessel, such as a venous vessel.

In one aspect of the invention, apparatus is provided to close a woundin a patient's tissue where the wound presents an insertion site and anelongated, obliquely oriented tract extending into the patient's tissueand in communication with the insertion site. Such apparatus comprises abody having an elongated, rigid force-transmitting surface and operableto be placed in an external wound-closing position with theforce-transmitting surface proximal to the patient's skin, adjacent thewound and in general axial alignment with the tract. A force-exertingassembly is coupled with the body and is operable to exert forces ofdifferent magnitudes at different locations along the length of theforce-transmitting surface in order to close the wound. In preferredforms, the force-transmitting surface is three-dimensionally asymmetric,and comprises first and second, preferably coplanar, surface sectionshaving different force-transmitting areas respectively. Also, a thirdforce-transmitting surface is provided which bridges the first andsecond surface sections and is generally T-shaped in configuration,presenting an elongated segment and a segment transverse to theelongated segment. Desirably, the elongated segment is obliquelyoriented relative to the first and second surface sections. Theforce-exerting assembly is operable to exert a force which generates aforce on the tissue of at least about 10 lbs., and more preferably atleast about 20 lbs.

The overall force-exerting assembly also includes structure for securingthe body to the patient's tissue, and a mechanism including a shiftablecomponent for generating a mechanically-derived force through theforce-transmitting surface. Such securement structure preferablycomprises a suture passing through the patient's tissue and tied to thebody to hold the body in the wound-closing position. The suture may bein the form of a known Z-stitch suture which serves to invert thepatient's skin at the wound site. The mechanism is preferably in theform of a biasing structure including at least one (and more preferablytwo) spring(s). Secondary forces may be generated by means of anadhesive sheet stretched over the device and adhered to the patient'sskin on opposite sides of the wound site.

Advantageously, the force-exerting assembly is designed to exert asubstantially constant and time-invariant force through theforce-transmitting surface; this, coupled with the preferred asymmetricforce application serves to reduce the patient's blood pressure and flowwithin the artery and especially at the arteriotomy.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded, upper perspective view of the preferredwound-closing apparatus of the invention;

FIG. 2 is an exploded, lower perspective view of the preferredwound-closing apparatus of the invention;

FIG. 3 is a side elevational view of the fully assembled apparatus;

FIG. 4 is an end view of the fully assembled apparatus;

FIG. 5 is a side view in partial vertical section illustrating the baseportion of the apparatus, with the force-exerting springs in thereleased position thereof;

FIG. 6 is a vertical sectional view taken along the line 6-6 of FIG. 5;

FIG. 7 is a vertical sectional view taken along the line 7-7 of FIG. 5;

FIG. 8 is a side view in partial vertical section illustrating the baseportion of the apparatus, with the force-exerting springs in the cockedposition thereof;

FIG. 9 is a vertical section view taken along the 9-9 of FIG. 8;

FIG. 10 is a vertical section view taken along the line 10-10 of FIG. 3;

FIG. 11 is a top view illustrating a catheter sheath positioned within awound attendant to a vascular procedure, and further illustrating thefirst step in the preferred method of the invention wherein a Z-shapedstitch has been created with a suture in the patient's tissue;

FIG. 12 is a sectional view of the wound, sheath, and suture depicted inFIG. 11;

FIG. 13 is a top view illustrating the next step in the preferred methodwherein the ends of the suture are tied to define an X-shaped stitchover the patient's skin;

FIG. 14 is an end view in partial section illustrating the next step inthe preferred method wherein the X-shaped stitch is tightened to invertthe patient's skin adjacent the wound opening and the base of theapparatus is pressed downwardly over the stitch and wound opening;

FIG. 15 is a sectional view of the steps depicted in FIG. 14;

FIG. 16 is a top view of the steps illustrated in FIGS. 14 and 15, withthe apparatus base illustrated in phantom and also showing withdrawal ofthe catheter sheath from the wound tract;

FIG. 17 is a top view of the next step of the method wherein the ends ofthe suture are passed around the rotatable operator forming a part ofthe apparatus base and knotted;

FIG. 18 is a sectional view illustrating the position of the apparatusbase and operator after the tying and knotting step illustrated in FIG.17;

FIG. 19 is a view similar to that of FIG. 18, but illustrating theoperator rotated to allow the force-exerting springs of the base to movefrom the cocked to the released position thereof so as to close thewound tract and reduce blood flow through the patient's artery adjacentthe wound arteriotomy;

FIG. 20 is a side view of the installed apparatus with a cover securedto the base and with a stretch of adhesive passed over the cover andsecured to the patient's tissue on opposite sides of the wound andapparatus;

FIG. 21 is a vertical sectional view of the fully installed apparatusillustrated in FIG. 20;

FIG. 22 is a top view of a preferred additional method step wherein adam is placed around the wound opening and the sheath, and a hemostaticpowder is deposited within the confines of the dam and over the woundopening; and

FIG. 23 is a top view of the condition of the patient's tissue afterwound closure and with the patient ambulatory.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The Preferred WoundClosure Apparatus

Turning now to the drawings, apparatus 30 operable to close a wound in apatient's tissue is illustrated in FIGS. 1-4. The apparatus 30 isparticularly designed for closure of wounds attendant to an endovascular(i.e., arterial or venous) intervention involving, e.g., a femoralartery puncture where the wound presents an insertion site, anelongated, obliquely oriented tract extending into the patient's tissueand communicating with the insertion site and an arteriotomy. Broadlyspeaking, the apparatus 30 includes a force-transmitting body 32 havinga force-exerting assembly 34 together with a removable cover or “hat”36.

As used herein, terms such as “upper” and “lower,” “top and “bottom,”and “downwardly” and “upwardly” and the like are used for convenienceand because of the fact that the apparatus 30 is normally positioned inan upright orientation on a patient with the cover 36 being directlyabove the body 32. However, if the apparatus 30 were to be placed in adifferent orientation (e.g., sideways) the cover 36 would nonetheless bedeemed to be above the body 32, and the above terms are intended toembrace all such different orientations.

In more detail, the body 32 is of rigid unitary construction and isformed of an appropriate synthetic resin material. The body 32 has firstand second, axially aligned cup-like sections 38 and 40, each with anarcuate, upstanding sidewall 42, 44, a bifurcated, rectilinear end wall46, 48, and a bottom wall 50, 52 serving to interconnect the section 38,40. A pair of grooves 54 and 56 are provided between each of the endwall bifurcations as best seen in FIG. 2. The bottom walls 50, 52 areconfigured to present first and second substantially flat and coplanarforce-transmitting sections 58 and 60; it will be observed that the areaof section 58 is smaller than that of section 60, and this is importantfor purposes to be described.

A protruding, downwardly extending segment 62 bridges and is integralwith the bottom walls 50, 52 and presents a lowermost, generallyT-shaped third force-transmitting surface 64 which bridges the sections38 and 40. The surface 64 presents an elongated, obliquely oriented andprogressively tapered segment 66 extending from the end of bottom wall52 to a point below bottom wall 50. Another surface segment 68 isgenerally transverse to the elongated segment 66 and is substantiallycentrally located below bottom wall 50. The segment 62 further includesa generally U-shaped sidewall 70 extending downwardly from the bottomwalls 50, 52 of the sections 38, 40.

It will be appreciated that the body 32 presents an overallforce-transmitting surface 72 made up of the force-transmitting sections58, 60, 64, and 68. This surface 72 is three-dimensionally asymmetricowing to the fact that the area of first surface section 58 is less thanthat of the second surface section 60 (so that the overall surface 72 isasymmetric in a fore-and-aft direction), and because of the fact thatthe inclined surface segment 66 and transverse surface segment 68 arepositioned below the first and second sections 58, 60 (so that theoverall surface 72 is asymmetric in a vertical direction). Moreover, theinclined segment 66 provides an increasing and progressive forcegradient from the second surface section 60 to the transverse segment68.

The sections 38 and 40 are each equipped with an upstanding, slotted,tubular member 74 or 76 which extend upwardly from the upper surfaces ofthe corresponding bottom walls 50, 52. As best seen in FIGS. 5 and 8, anelongated, downwardly extending cylindrical opening 78 is formed inbottom wall 50 and protruding segment 62 directly beneath and coaxialwith the tubular member 74. Likewise, a shorter, downwardly extendingcylindrical opening 80 is provided directly beneath and coaxial withtubular member 76. Each of the openings 78, 80 has a plurality ofelongated, upright, circumferentially spaced apart, inwardly extending,integral ribs 82.

The configuration of the tubular members 74, 76 is identical, andtherefore only the construction of member 74 will be described indetail. Specifically, member 74 has an upstanding sidewall 84 with apair of specially configured and opposed slots 86 formed therein. Thesidewall 84 is reinforced by means of external gussets 88 and braces 90.Each slot 86 includes a lowermost, substantially frusto-circular portion92, an intermediate upright portion 94, and an uppermost, inwardlyextending lip portion 96.

The force-exerting assembly 34 generally includes a pair of identical,helically coiled springs 98, 100 respectively housed within acorresponding tubular member 74, 76 and supported therein by means ofthe adjacent upstanding ribs 82. The overall assembly 34 furtherincludes an elongated, axially rotatable paddle-like operator 102, whichextends fore and aft and is received by the opposed slots 86, so thatthe operator extends through and is supported by both of the tubularmembers 74, 76 and engages the springs 98, 100. The operator 102 islikewise formed of synthetic resin material and includes a centralsegment 104, a pair of identical, elongated, slotted, oval-shapedsegments 106 and 108 on opposite sides of the central segment 104, andfore-and-aft segments 110, 112.

Referring to FIG. 5, it will be observed that the central segment 104 iscylindrical in configuration and has a central, peripheral,suture-receiving groove 114 formed therein. The oval segments 106, 108are situated within the tubular members 74, 76 and have major axes 116and transverse, minor axes 118 (FIG. 6). The fore end segment 110 has arounded outer edge, whereas the corresponding aft end segment 112 has arecessed trailing edge. In this fashion, the operator 102 has anarrow-like shape along the length thereof.

The operator 102 serves to allow selective compression of the springs98, 100 so as to maintain the springs in a cocked position as best seenin FIGS. 8 and 9. Upon 90° rotation of operator 102, the springs 98, 100are released to a force-exerting position illustrated in FIGS. 5-7 and10. In more detail, if it is desired to cock the springs 98, 100, theoperator 102, in the FIG. 5-7 position where the major axes 116 areupright, is pressed downwardly through the upright portions 94 of theslots 86 until the bottom peripheries of the oval segments 106, 108engage the bottoms of the frusto-circular portions 92. Thereupon, theoperator 102 is rotated 90° in either direction so that the major axes116 are substantially horizontal and the oval segments 106, 108 arecaptively retained by the frusto-circular portions 92. When it isdesired to release the springs 98, 100, this operation is reversed,i.e., the operator 102 is rotated 90° until the major axes are againupright. The springs 98, 100 then urge the operator 102 upwardly to theFIGS. 5-7 position, with the lip portions 96 of the slots 86 serving toretain the operator 102 within the slots 86.

The cover 36 includes an uppermost wall 120 which is gently arcuate incross-section and presents an upper surface 122 and a lower surface 124.A pair of depending, slotted tubular members 126, 128 extend from bottomsurface 124 and are in alignment with the tubular members 74, 76. Themembers 126, 128 are identical, and therefore only member 126 will bedescribed in detail. As best seen in FIGS. 1, 2, and 4, the member 126includes a sidewall 130 with a pair of opposed slots 132. Each slot 132includes an uppermost arcuate portion 134 and a substantiallyrectilinear portion 136. The tubular members 126, 128 are of slightlylarger diameter than the corresponding tubular members 74, 76, allowingthe cover 36 to be positioned over body 32 and pressed downwardly overthe tubular members 74, 76 to assume the position depicted in FIGS. 3-4.It will be observed in this respect that the slots 86 of the tubularmembers 74, 76 are in substantial alignment with the slots 132 of thetubular members 126, 128.

Preferred Method of Use of the Wound Closure Apparatus

The preferred method of using the apparatus 30 is depicted in FIGS.11-23, in the context of the closure of a femoral artery puncture wound138 (FIG. 12). It is to be understood, however, that the ensuingdiscussion is exemplary only, and that the invention can be used invirtually every type of endovascular arterial or venous intervention.

The wound 138 is in the groin tissue 140 of a patient and includes aninsertion site 142, an elongated, obliquely extending tract 144extending from insertion site 142 and terminating at an arteriotomy 146in the femoral artery 148. A conventional catheter sheath 150 ispositioned within the tract 144 in order to permit an endovascularprocedure using a catheter (not shown). When the procedure is completedand the catheter removed, it is necessary to promptly close the wound138 during removal of the sheath 150, while minimizing any blood lossand rendering the patient ambulatory in as short a period as possible.

In order to facilitate the description of the preferred wound closuretechnique, the direction towards the patient's heart is denominated as“north,” whereas the direction leading away from the heart isdenominated “south.” Correspondingly, transverse directions aredenominated as “east” and “west,” respectively. Accordingly, it will beobserved that the tract 144 extends from the insertion site 142 to thearteriotomy 146 in a generally northerly direction.

In the first step of the wound closure procedure, the endovascularphysician creates a Z-stitch 154 (FIGS. 11-12) in the patient's tissue140 by passing a suture 156 through an entrance 158 east of the artery148 and south of insertion site 142, an exit 160 west of artery 148 andsouth of insertion site 142, an entrance 162 north of insertion site 142and east of artery 148, and finally an exit 164. The end of the suture156 adjacent entrance 158 is then clipped. The stitch 154 thus includesexterior suture stretches 166 and 168, embedded suture stretches 170 and172 above artery 148 at a depth of less than about one-half inch, and anobliquely extending exterior stretch 174 extending between the exit 160and entrance 162.

In the next step (FIG. 13), the exterior suture stretches 166 and 168are crossed and interconnected by folding the stretches over each other,thereby creating an X-stitch 176 with a central suture fold 178, andwith the free ends 166 a, 168 a of the exterior suture stretches 166,168 extending westerly and easterly, respectively. Preferably, thesuture fold 178 is positioned in very close proximity or over theinsertion site 142.

The next step (FIGS. 14-18) requires two health care providers andgenerally involves tightening of the X-stitch 176 while theforce-transmitting body 32 of apparatus 30 is positioned atop wound 138with application of a downwardly directed force, and the sheath 150 isremoved. In detail, one care provider grasps the free suture ends 166 a,and 168 a, and pulls these in an easterly and westerly direction,respectively. This serves to tighten the suture while inverting thepatient's skin tissue, as illustrated by numeral 180, at the region ofthe insertion site 142. That is, uninvolved, parallel peripheral tissueis forced upwardly, while the central tissue adjacent the wound ispushed downwardly over the entire insertion site 142, tract 144, andarteriotomy 146. The inverted tissue in cross-section thus resembles anM in shape.

Once the skin is inverted, the second provider presses body 32 (which isin the spring-cocked position thereof) downwardly into the patient'stissue 140, while withdrawing the sheath 150. In particular, the body 32is located in general north-south alignment with the artery 148, suchthat the force-transmitting surface sections 58 and 68 are above andnorth of insertion site 142 and arteriotomy 146, with the obliquesection 64 over the suture fold 178, and with the rearmost portion ofsurface section 60 located south of the insertion site 142. As the body32 is held in this position, the first provider, while still maintainingtension on the suture free ends 166 a and 168 a, pulls the ends upwardlythrough the body grooves 54 and over the central segment 104 of operator102, and forms a secure knot 182 at the top surface of the segment 104.In this condition (see FIGS. 17-18) the artery upstream of arteriotomy146 is partially closed, whereas tract 144 and arteriotomy 146 are fullyclosed.

In preferred practice, the suture ends 166 a, 168 a are pulled upwardlywhile avoiding any twisting prior to formation of the knot 182. Thisavoids reduction in the burst strength of the suture ends. That is, ifthe ends are twisted prior to knotting, the burst strength of the sutureends is reduced and can induce premature failure of apparatus 30.

In order to establish and maintain a substantially constant andtime-invariant wound closure force, the operator 102 is rotated 90° sothat the springs 98, 100 are released to their force-exerting positions(FIGS. 5-7 and 19). This serves to maintain the suture 156 in tension soas to firmly draw the body 32 into the wound-closure position while alsomaintaining a substantially even force based upon the strengths of thesprings 98, 100. Preferably, the tensile force exerted on the suture 156is slightly below the burst strength thereof; thus, the tensile force onsuture 156 should typically be 10-15% less than the suture burststrength.

Next, the cover 36 is positioned atop body 32 by pressing the tubularmembers 126, 128 over the tubular member 74, 76 until the cover isfirmly seated. At this point, a length of wide adhesive material 184(e.g., 6×8 inches) is placed over the cover 36 with the ends of thematerial 184 being pulled downwardly and adhesively attached to thepatient's tissue at east and west and north and south locations,respectively. This material 184 may be stretchable or non-stretchable,and if desired may be breathable. Placement of the material 184 servesto exert a secondary force through the body 32, in addition to thatexerted by the springs 98, 100, while also stabilizing the apparatus 30on the patient. Advantageously, the height of the apparatus 30 aboveinsertion site 142 divided by the maximum east-west transverse dimensionof the force-transmitting surface 72 is greater than 1. With this ratio,the vertical component of the force generated by the material 184 isincreased, causing additional force to be applied over the entirety ofthe wound.

As finally positioned, the apparatus 30 creates targeted, asymmetrictissue pressures from north to south. At the north, a larger,non-occlusive pressure is applied upstream of the arteriotomy 146 inorder to lower the patient's blood pressure and blood flow at thedownstream arteriotomy. The transverse surface segment 68, positioneddirectly above the arteriotomy 146, closely mimics a properly executedtwo-handed manual wound closure. The lesser tissue pressures createdsouth of the arteriotomy 146, owing to the decreasing force gradientgenerated through the oblique section 66, and the greater surface areaof southernmost section 60, also are similar to such manual closure.

FIG. 22 depicts another preferred aspect of the invention, namely theuse of a compressible dam 186 having a central opening 188 over thewound. In particular, the dam is placed in surrounding relationship tothe insertion site 142 and a hemostatic powder 190 is sprinkled into theopening 188 (about 0.3 g). This procedure is carried out prior totensioning of the suture free ends 166 a, 168 a, and placement of theapparatus 30 on the wound site, as previously described. Of course, thedam remains in place during the entire closure sequence, and is thenremoved after closure. The hemostatic powder 190 may be a cationicsurfactant combined with a strong acid cation exchange resin, or apotassium ferrate/strong acid cation exchange resin. Preferably, thepowder 190 is of the type described in U.S. Pat. No. 6,187,347. Inanother embodiment, a sheet of exudate-absorbing woven or non-wovenhemostatic material (such as oxidized cellulose or chitosan) may be usedin lieu of or in addition to the powder 190.

FIG. 23 illustrates the condition of the wound 138 at the completion ofwound closure. After the appropriate closure time, the knotted suture156 is cut and the apparatus 30 is removed from the wound 138. It willbe seen that the insertion site 142 is closed (clotted) with the sutureopenings likewise closed. If desired or needed, a hemostatic/antisepticpowder can be sprinkled over the insertion site and the suture openingsto help prevent infections and inhibit oozing. Normally, no dressing isrequired, and the loose powder is merely brushed off the wound site.

A significant advantage of the invention is that TTAs are substantiallyreduced. In the case of diagnostic procedures, TTAs on the order of 60minutes are common, and with more complex interventional procedures,TTAs of 120 minutes are typical. In a pre-clinical study involving 100patients with interventional procedures up to 12 Fr, the preferredapparatus of the invention closed the patients' wounds with nocomplications and TTAs of less than 120 minutes

The invention also is useful with seriously obese patients. With suchpatients, the panniculus descends to the femoral insertion site,interfering with normal deployment of closure devices. This restrictsthe space around the wound and the ability of the healthcareprofessional to properly apply manual closure pressure. However, in thepresent invention, pre-compression of the springs 98, 100 and latchingthem with the operator 102 allows the device to be aligned over thewound and the knot 182 tied. Thereupon, the operator 102 is rotated torelease the springs, and the material 184 is applied.

Those skilled in the art will appreciate that the preferred embodimentof the invention may be modified in many ways while still achieving theaims of the invention. For example, while identical springs 98, 100 arepreferred, springs of different strengths and/or types may be used,e.g., flat and coiled springs. The springs may be attached to the lowerbody or the top cover of the apparatus, at the discretion of thedesigner. Additionally, the invention may be practiced without the useof the Z-stitch suture 156. In this embodiment, a spring force isgenerated directly against the top cover by manually placing the coverin direct contact with the spring(s). Then an adhesive material or film184 is brought over the cover and pressed downwardly to compress thespring(s) and hold the device in place by adhering the film to thepatient's skin on either side of the wound 138. Such an embodiment isuseful, for example, on very thin elderly patients whose skin is sofragile that sutures are not effective to retain the device in place.

1. A method of closing a wound in a patient's tissue, said woundpresenting an insertion site opening and an elongated, obliquelyoriented tract extending into said patient's tissue and in communicationwith said opening, said method comprising the steps of: positioning abody in a wound-closing position proximal to the patient's skin andadjacent and in spanning relationship to said wound, said body having anelongated force-transmitting surface having a length greater than thewidth thereof and positioned in general axial alignment with said tract;and exerting a force through said force-transmitting surface in order toclose the wound, said force having different magnitudes of pressure atdifferent locations along the length of said force-transmitting surface,said force being greatest adjacent one end of said force-transmittingsurface closest to the patient's heart, and decreasing along the lengthof the force-transmitting surface away from the patient's heart.
 2. Themethod of claim 1, including the step of exerting said forcesubstantially invariantly over a period of time to close said wound. 3.The method of claim 1, said force-exerting step comprising the steps ofpassing a suture through the patient's tissue at a point adjacent tosaid insertion site, tying said body with the ends of said suture, andgenerating a mechanically-derived force in order to exert said forcethrough said force-transmitting surface against the patient's tissue. 4.The method of claim 3, said body supporting a plurality of spaced apartsprings and an operator engaging said springs, said operator shiftablebetween a first orientation maintaining said springs in a cockedposition, and a second orientation allowing said springs to generatesaid mechanically-derived force, said force-exerting step comprising thestep of shifting said operator to said second orientation, said operatorcomprising an elongated, axially rotatable paddle, said paddle havingstructure for maintaining said springs in said cocked position at afirst orientation thereof, and for allowing the springs to exert saidforce upon rotation of the paddle to a second orientation.
 5. The methodof claim 4, said body having a pair of generally spaced apart tubularspring retainers with one of said plurality of springs within eachretainer, said spring retainers each having recesses for receiving saidoperator and allowing selective axial rotation thereof, said operatorhaving respective sections passing through said retainers and engagingthe spring therein, said operator shiftable between a firstspring-cocking position wherein said springs are held in said cockedpositions thereof, and a second spring-releasing position wherein saidsprings are released from said cocked positions thereof.
 6. The methodof claim 5, said operator sections being generally oval in cross-sectionand presenting major and minor axes, said spring retainer recessesconfigured to retain said operator sections in said first positionsthereof when the operator is oriented so that said major axes extend inone direction, and to release said springs when said operator isoriented with said major axes in a second, different direction.
 7. Themethod of claim 1, said wound tract communicating with an opening formedin a vascular vessel within the patient's tissue, said body andforce-exerting assembly cooperatively configured to reduce the bloodpressure within and downstream of said vascular vessel.
 8. A method ofclosing a wound in a patient's tissue, said wound presenting aninsertion site opening and an elongated, obliquely oriented tractextending into said patient's tissue and in communication with saidopening, said method comprising the steps of: positioning a body in awound-closing position proximal to the patient's skin and adjacent andin spanning relationship to said wound, said body having an elongatedforce-transmitting surface having a length greater than the widththereof and positioned in general axial alignment with said tract; andexerting a force through said force-transmitting surface in order toclose the wound, said force having different magnitudes of pressure atdifferent locations along the length of said force-transmitting surface,said force-exerting step comprising the steps of passing a suturethrough the patient's tissue at a point adjacent to said insertion site,tying said body with the ends of said suture, and generating amechanically-derived force in order to exert said force through saidforce-transmitting surface against the patient's tissue, saidforce-generating step comprising the step of exerting a force through aspring operably supported by said body.
 9. The method of claim 8, saidexerted force being greatest adjacent one end of said force-transmittingsurface closest to the patient's heart, and decreasing along the lengthof the force-transmitting surface away from the patient's heart.
 10. Themethod of claim 8, said body supporting a plurality of spaced apartsprings and an operator engaging said springs, said operator shiftablebetween a first orientation maintaining said springs in a cockedposition, and a second orientation allowing said springs to generatesaid mechanically-derived force, said force-exerting step comprising thestep of shifting said operator to said second orientation, said operatorcomprising an elongated, axially rotatable paddle, said paddle havingstructure for maintaining said springs in said cocked position at afirst orientation thereof, and for allowing the springs to exert saidforce upon rotation of the paddle to a second orientation.